the public that there are, in fact, rules and regulations that they need to follow. when we see these public announcements of individuals being fined or otherwise the faa acting on them, that probably is going to have to be one of the incentives as well. >> even the existing regulations assuming they were in force. let's assume i buy a quad copter and put a goat cam on it and go to my friend's ranch and film deer around a deer field. i'm perfectly legal at this point. i post that to my blog that has google ads on it all of a sudden i've probably crossed into a gray area of commercial use. and i mean, that's -- that's a lot of fine line distinctions to have to educate the public about. >> i can't argue with that sir you're right. >> all right. ms. gilligan i'll give you an opportunity to answer my question or concern that we're operating at the speed of the

internet and if we can't -- if our regulations can't keep up technology and there's so many of them out there we're really going to have a dangerous situation. is there a sense of urgency? >> yes, sir. there is within the faa. as i commented in my opening remarks, our small uas rule has been delayed beyond what any of us think is acceptable but we believed our balanced proposal will be out shortly and we'll start to get comment and finalize those rules. >> thank you very much. i see my time has expired. >> mr. massey. >> thank you mr. chairman. ms. gilligan, you mentioned that a rule would be coming out short ly and mr. hampton you've documented the ways that we're kind of behind schedule. i understand that things rarely go according to schedule whether you're in the private sector or the public sector, but when you say a rule is going to be coming out shortly, to quote a colleague, is that in a

geological time scale or an internet speed? >> the proposal is under executive review at this point sir, so i really can't tell you exactly what the timeframe is. but, as i said, all of us who are involved in the project understand how important it is to get this out as quickly as we can now. >> i would be remiss in my oversight responsibility here if i didn't get a date or some kind of commitment at this hearing so that when we're at the next hearing, we can measure progress toward that. what are some of your goals in the next year? >> well, for the rulemaking the department of transportation has a public website which shows the rules scheduled for release by the end of this year. once the rule is released it will go out for public comment. that period will last anywhere between 60 and 90 days depending on what the community asks for. there's a concern that we'll get a substantial number of comments which will delay how quickly we can get to the final rule. but we'll certainly keep the committee informed of how we are

progressing once we're able to publish the rule. >> to ms. esty's point earlier how are we going to make sure these rules are copacetic with the next-gen is it putting adsb in every drone? is that going to be one of the answers? would that allow them to interoperate? >> well, sir i can't really comment on what's in the rule because it's a pending rule making. but we have a industry very tightly involved with us in determining what should be the design standards for these kinds of platforms, if -- when they are to be certified by the faa. so we'll base our decisions on what the community recommends. >> one of my concerns for drones in the commercial development of them is if you require something like adsb and there's no low cost solution to that, are we throwing up another impediment because the low cost solution to adsb doesn't exist right now for

private aircraft and do you see any progress in that field? >> well, again, the industry, members of the committees who ared aing are advising us know they must address the risks to sense and avoid other aircraft and for tun manned platform to be able to be seen by both controllers and pilots in the system. they're looking -- working hard on what exactly those technology solutions can be. and we're sure they'll find them. >> i know you don't want to comment on rule because it's not been released but can you give us some indication, is it going to be risk-based or to what degree will you incorporate those recommendations of a risk-based strategy? >> i can tell you that we did take a risk-based approach. it is the approach we use now for all of our standards. we also look at performance standards rather than directing particular technology solutions for example. and those are just the general policies that we follow.

>> so i've got a question for mr. kallman or dr. roy here. some experts have talked about integrating privacy by design. you know we're talking about safety. what about privacy here? this is a genuine concern that the larger public has i think. are you aware of any technology solutions to the privacy issue? >> to the privacy issue, i think it's important to state that privacy is definitely one of the things of utmost importance for the uas industry. privacy by design. a lot of manufacturers are engaging in this today and doing things like restricting where and where cameras can turn on and protecting that information. but ultimately i feel that privacy is really independent of the type of technology that's collecting that information. i feel that privacy is really about what information is

private, what information is public and insuring that we protect that independent of different types of collection methods. >> dr. roy. >> i'd also like to add that privacy is a little bit of a moving target. it varies from not just country o to country but across the u.s. as well. it's really a question of expectations. i think that when we talk about -- your suggestion privacy technology i think so long as the public understands what information is being collected and has clarity into that, then that will go a long way towards actually defining privacy. >> quick question, i don't know if there will be time for an answer, but one of the things in addition to a ceiling that i'd like to see is a floor. what's the reasonable expectation on your property if something's an inch above the ground is it trespassing? if it's ten feet bub the ground is it trespassing and you have the right to engage a trespass trespasser. so that's something i'd like to see considered along the privacy lines.

i think my time has expired. >> it has. >> thank you, mr. chairman. >> mr. larson. >> thank you mr. chairman. i understand because of the number of folks you have and the folks we have that we'll go two to your side and one to our side and get through this. i want to yield a little bit of time to mr. defazio who has a question, then i'll take the rest of the five minutes. >> i thank the gentleman. try and do this quickly. when we see these things in the new york air space have we found anybody operating illegally who was putting people at risk? i mean, you've talked about some commercial violations. have you caught anybody who has like put people at risk with one of these things? >> i can't make the corerelation to some of the reports we had. >> right because we don't know who is operating them who owns them, anything. how about a system where we require registration, licensure the user fees go to help you with your deficiencies in your

budget and you vary the license according to the uses and the weight and the capabilities so that the cost for, you know, would be appropriate so it won't be burdensome on little small, but so anyway think about that. there's no real answer now, but i thinks that the way to go. we need to know who has these things, who is operating them and, you know, people are putting people at risk taking a plane down, they got to be prosecuted. thank you. >> thank you. mr. hampton the faa uas working group has recommend the integration office be placed at a higher level in the faa. have you looked at or do you have an assessment moving the uas integration office would help coordinate efforts better across the agency? >> sorry about that. that's a very good question. in industry, that's a very significant concern. at this time i think we're more concerned about outcomes.

and as going forward in the reauthorization process, i think we've have to look a year from now and see the outcomes and whether things have advanced. we're going to -- faa is going to quickly move from a situation from actually planning to actual execution on a number of fronts. so i think we'd have to wait in about a year from now and see where we've gone with the execution of the rule, whether we've gone where faa's response to a number of our recommendations on developing and executing a framework for collecting data where we've come with the test sites, so i think that's a very real possibility. i think the key -- i'm not really too concerned about how faa's organized and structured, but outcomes sir. i think that's a very, very good question. the office was structured and it does a very good job of coordinating. a year ago we were concerned about staffing levels. they staffed up. we're also concerned about the requirements of what's important for it to actually begin to develop the regulatory framework, do controller

training, so requirements and the position of the office to execute things and make things happen with a sense of urgency, so i think we'd have to take a look at that in about six months to a year, sir. >> just for the record i'm hopeful we'll be done with this reauthorization well before that year is up. >> yes, sir. >> dr. gillingham, from your discussion with test site operators and holders do you have any idea how test site levels could increase participation in the u.s. integration efforts? >> yes, mr. larson. in our conversations with the test sites, in addition to the blanket coa that ms. gilligan talked about and the appointment of the air worthiness director the test sites also talked about perhaps they could be a part of faa's approval process of the section

333s. that number is going to increase and it's a workload burden on faa. we're hearing that it will be two or three years before we have a rule so in the meantime any tools that are available to further the idea of commercial use of uas would certainly be helpful. the idea something was talked about earlier again is sort of the development of an integrated budget that allows faa to be more supportive of the test sites as well as again we bring back are there issues around the anti-deficiency law that can be somehow dealt with so that it allows faa to adhere to the law but also be supportive of the test sites. >> captain moak just one final question on this.

how are pilots communicating near misses to faa? is there a structured way to do that and are you confident that every near miss that is seen is being reported? >> so if you see one of these you're going to take action to avoid it. you're then going to report it to the controlling authority. so if we're out in the approach corridor, we'll be talking to approach and let them know immediately so that they can make sure someone else doesn't go in the same air space. if we're on the tower frequency we would report it to tower at that time. then on the -- once we're on the ground safely and have gotten to the gate, we have an asep reporting program that we work with in the faa and the companies with. we report it through that so that everybody can know about

it. i'm not confident -- i am confident that when someone cease it, we're reporting it. i'm not confident that we're seeing them. because they're very small and, like i was saying earlier, we don't have any indication in the airplane like we do with t-cass with the other aircraft and the relative motion necessary for your eye to be able to pick it up is difficult, especially this size and maybe just a little bigger. so it is a real issue. our pilots are reporting them. and we just need to stay on top of it. i'd like to see us take some kind of construct on this type of problem that we took with the green laser problem we were having and we became a lot more successful on reporting and also prosecution of people that were pointing those lasers at pilots on flying. >> thank you. >> mr. davis? >> thank you, mr. chairman. i echo the comments of chairman

lobiondo and chairman shuster, both from a safety perspective as well as an opportunity for economic growth. the briefing materials that we were provided by the committee cite that this -- that uas systems will have a $200 billion impact and provide jobs up to 2025. my questions should be viewed through that lens. i'd like to start with associate administrator gilligan. one thing i say with uas is more efficiency in rural areas, like the one i represent, viewing farmland and precision agricult agriculture. and make sure we have proper drainage and better production, better environmental impact. so one thing that can hamper this is a requirement. if the rule required a pilot's license in order for a farmer to operate a uav, can you confirm

the small uas rule would require a farmer to get a pilot's license in order to use one. >> unfortunately sir, because we're in rule making i'm not able to talk about what's contained in the rule. we're mindful, however, of the -- how easily uas could be applied to agricultural operations. of course we also have a very active ad pilot community we're dealing with who are concerned about operating in air space with these kinds of platforms. so we're looking at how we can address all of those safety risks and how they can be mitigated. >> thank you. please note my concern requiring that, if that is going to be part of the rule. dr. roy, the faa's slow pace may be causing our best and brightest to maybe leave the united states, especially when you look at major u.s. tech companies that have moved their research and development operations overseas. do your students have better job

opportunities outside the united states in this field? >> the field is small right now. commercial uavs. so the job opportunities are few and far between in the u.s. and other countries, but i think you've heard from several people that the rate at which the opportunities are growing in other countries possibly is going to lead to a lot more opportunities. i'd say that the -- it's immeasurably small around the world right now but i would worry that there are many more -- i personally am seeing more start-ups. very small start-ups but more start-ups outside the u.s. than inside the u.s. >> one of the major issues with uavs is the flyaway problem. loose koectivity and flyaway. it affects consumer uavs and also high end aircraft with the military. how do we mitigate that risk and integrate this into our aviation system? >> yeah, and i tong reiterate

also that safety again is of utmost importance. with the flyaway issues that's a matter of technology. i think that the technology is increasing at a very rapid pace. i mentioned earlier a lot of functionality and a lot of these systems to manage issues. you'll lose the gps or something along those lines. so making sure systems have the ability to know how to automatically respond should any system fail on board the aircraft and be able to return it to a location that's determined safe before the flight. those will be very important to insure. >> safety is paramount on the flight simulators many of your pilots use to train. is there a simulation for uavs? >> not per se. there is simulation for, you

know detect and avoid. visually pick up something or if you have a situation where you're losing control because perhaps you had to maneuver it. maneuver it in a manner that you wouldn't normally be maneuvering it meaning you were banking it excessively and how you recover from that upset situation. >> thank you for being here today. this is an issue we should be able to address. we've seen unmanned aircraft fly sorties within the theater of war in a much smaller area than they've done it safely. we ought to be able to not fall behind countries like canada in put together a rule making process so that we can get commercial uavs into the marketplace and do it in a way that's going to be safe. i have concerns too, with our

medical helicopters. i'm in the flight line of my house in taylorville illinois. i want to make sure we have these rules in place we can do this. i appreciate your work and look forward to hearing you at the next hearing. >> thank you mr. grace. >> thank you, mr. chairman. i think most all the questions have been asked. a couple of comments i would like to make. i was pleased to hear miss gilligan mention agriculture because i am very concerned about that. during the periods between may and august at least in the midwest, we have heavy traffic at and below 300 feet. that's going to and from the airport. and that's on the site where they are spraying too, and it's a big concern. there is a huge potential out there for uavs and agriculture sector. but they are in that same air space and it concerns me a great deal. this comes down to, and captain

mngsed it. comes down to visibility being able to see these things. i don't think transponders are necessarily the answer. that gives air traffic control visibility on them but if you are on a flight plan you aren't talking to air traffic control you don't have the benefit of that sight. if we put adsb out anthem that's going to paint them but you have to have it in to be able to read that as well. and it still comes down to situational awareness and the people flying the manned aircraft have the manual awareness. but traveling 100 knots up to our airline traveling 350 knots and everything in between you're moving pretty fast and

that's awfully small and very hard to see it particularly if there is no relative motion. i've got a huge concern with how we're going to move forward. i'm not so sure we don't need to take a more active role in congress when it comes to reauthorization. but it concerns me in a big way. we haven't begown talk about the safety of individuals on the ground when these things do go rogue and what happens to those folks? we're just talking about aviation and the potential. i don't want to run into one. interestingly enough, there are a lot of birds out there and we have bird strikes but birds have situational awareness, too, and they'll get out of your way, for the most part. but this is a big concern. there is no question in that. we need to move very, very carefully as we move forward.

>> thank you. mr. williams. >> thank you, mr. chairman. i'd like to thank all of you for being here today. appreciate it. i'm from texas. we've got a lot of air space in texas. and my question to you would be ms. gilligan, as companies look for economical ways to modernize their delivery systems, unmanned aircraft systems are looking more and more attractive as we learned today. amazon prime air is currently investigating the possibility of using small drones to quickly deliver their packages to their customers. my office has met with amazon prime and learned they are having some difficulties getting permission from the faa to test their delivery system outdoors in a rural area in washington state. would you please give this subcommittee an update on amazon primary's petition under the faa modernization reform act of 2012 that will allow them to test this system outside here and in the u.s.? >> why sir i'd be glad to.

they have applied for the exemption, and we've worked closely with amazon. we've been in regular contact with amazon since i would say, over a year ago when they began pursuing this project. we believe though, to some extent what they want to be able to do they can do under a -- with a research certification for the vehicle. we're also working with them an taking that approach because we feel that will fit their needs betters. they are having those conversation conversations. we know they are not satisfied that they have to go that path but i'm certain we'll reach some conclusion shortly so we and they can figure out how to support twhat is they are trying to do. >> my second question would be also to you. looking to the future, do you see a time when the faa will have an assistant administrator for unmanned aircraft systems. if not why? and what is the faa doing to prepare for this change? >> we believe unmanned systems are like many other of the

technologies that we've brought into the system over the years. so we do believe there will be full integration and that will be handled within the structure that we currently have. we do not see a need at this point for a separate organization because we need to make sure that the aircraft itself and those systems are integrated in design and manufacture with the aviation system and the operations are integrated with the operation of the rest of the aviation systems. that's the approach we're pursuing. >> thank you. mr. chairman i yield back. >> mr. yokida. >> i thank the chair. i'm not on the committee yet but i appreciate the time to ask some questions. i have six pages of notes here which for me sanis an all-time record so i can tell i'm going to hate being an this committee. i thank the witnesses for their testimony. if i heard your testimony correctly, it seemed like you were defending the faa process

here and where they are at when you said look, other countries might be ahead in terms of the regulatory schem attic but they're still going to incur the technical difficulties. did i get that accurately? >> that's correct. >> so then those cannots must be acting with reckless abandon or something. >> no i don't think that's true. >> then why can't we follow the same path? >> let me draw a distinction between a small number of flights that demonstrate capability or provide a service and the -- what is required in order to service all of say, agriculture in the u.s. so a good example is japan. so japan is sort of a high water mark in terms of precision agriculture. somewhere between 30% and 40%

are sprayed using yamaha rmx helicopters. one model of aircraft is providing service for about 77% of all the uav and it's doing so with about 2,000 aircraft. that's a very small number. the effort required to support that is relatively small. it's nice that japan and the other countries have the regulatory infrastructure in place, permission for testing that allows companies to go and develop their technology but what's required is another way of technology to scale up to the amazon prime air servicing all of d.c. or the boston area. and i think that next step is what's going to be required to really grow the markets everywhere. >> okay. thank you. i'd like to ask any of you if you're aware any of actuarial studies that have been done.

if we're talking about a risk-based approach and what you've all indicated that's a fine approach. insurance companies all day long do studies that analyze this using math. so if we're worried about a strike in an approach corridor around an airport, we could take the number of, let's say birds that are in a square mile of that airport or some area and then let's say it's 10000 or 20,000 or 100,000 whatever it is and then add the ten drones that would be in the area at the same time and see what the increased percentage of risk is. and then we could have a discussion based on science and math and not what -- not pictures and beliefs because the fact of the matter is a bird which has situational awareness. i completely agree. but it still can be -- still can determine what the risk is.

captain? >> so we have procedures for birds currently. so there if there are birds in the area, there's the atis system that the controllers are putting bird reports out. meteorologists are putting that information out. you can see some large flocks of birds on your radars. we have procedures if we were to have a bird strike. so there's all kinds of procedures for dealing with birds. it's not preferred method. >> but not a bird near a miss. you outlined a procedure for a uas near miss. >> bird near miss. we have a procedure for that. you report birds in the area because you know you have another plane coming right behind you. >> flocks of birds and that kind of thing on the airport and it's in the approach corridor but there's not the detail procedure you indicated for a -- >> there is. if you're going to hit a flock

of birds you're going to maneuver the airplane in a manner -- >> i meant you get down you call you -- then you alluded to a prosecution element that was inherent with the laser stuff, which is an intentional act. but my question is about the actuary studies. have there been any actuaryial studies? >> for the large aircraft that's the case. for the small aircraft i think the answer is no. there's a couple of reasons for that. we don't have good models -- good failure models for a lot of the parts and for the consequences of failures. so bird strike might be one that does exist but for a lot of other failure modes i'm reasonably certain they don't exist. >> they'd be helpful. >> they'd be extremely helpful. >> thank you. i yield back. >> if there are no further questions, i'd like to thank all

the witnesses for their testimony and in absentia, the other members for their participation in today's program. the subcommittee stands adjourned. here are some of the programs you'll find this weekend on the c-span networks. sunday evening at 8:00 on q&a politico report irs manuraju and john bresnahan share stories of being on the campaign trail with mitch mcconnell. on c-span 2, lindsay mark lewis on money and politics and how

it's grown and changed. sunday at 10:00 p.m., senior correspondent for "the daily beast" on the military's use of cyberspace to wage war. and an american history tv on c-span3, saturday at 2:00, a panel including "washington times" opinion editor david keen on how ronald reagan's career as an actor and spokesman for germ electric helped hone his communication skills. and sunday at 8:00 on the presidency, frank gannon former aide to president nixon shows clips of his 1983 drew sbroou with the president about vietnam, watergate and his resignation. find our complete schedule at c-span.org. call us at 202-626-3400. e-mail us at comments at c-span.org. join the c-span conversation. like us on facebook follow us on twitter.

the fda director of food safety testified at a house hearing wednesday about genetically modified foods. food safety groups have called for limits on farming of gmo crops and for mandatory food labeling. a second panel includes testimony from scientists and advocates for farmers and food companies. this hearing of the house energy and commerce subcommittee on health is three hours. >> they[÷ subcommittee will come to order. before we begin, i'd like to take a moment to address the guest in our audience. first of all, thank you all for coming. we think engaged citizens are a welcome and valuable part of the political process. i only wish every hearing drew this much interest. the purpose of this hearing is to examine fda's role in

regulating genetically modified food ingredients, and it is an opportunity for this committee to ask questions and have axac(t&háhp &hc% thoughtful discussion on this issue. the number of people in this audience and in the hallway this morning demonstrates the strong interest in this topic and we welcome that interest and your attendance here today. i do want to remind our guests that the chair is obligated under the rules of the house and rules of the committee to maintain order and preserve decorum in the committee room, and i know that we may not all agree on this topic but i ask that we all abide by these rules and be respectful of our3boñ audience members, our viewers and our witnesses. and the chair appreciates the audience's cooperation in maintaining order as we have a full discussion on this

important issue this morning. the chair will recognize himself for an opening statement. the genetically modified organisms or gmos, is a term that refers to ingredients sourced from crops that have been genetically engineered to express certain traits or carcistics. a number of people have an instinctive distrust of food that has been genetically modified. and are asking questions about its safety. others see great promise for better nutrition and the aleveiation of hunger around the world. there are real sensitivities around this issue and all issues regarding the food we eat and feed our children and our grandchildren. it is our job as policymakers, particularly as it relates to the public health, to establish a factually and scientifically

sound foundation prior to taking any action that would impact consumers and our economy. and this hearing provides a great opportunity to put rhetoric aside and do just that. gmos have been a part of the u.s. food supply since the mid-1990s. in fact as much as 90% of our corn sugar beet and soybean crops are now genetically engineered, and about 70% of processed foods contain such ingredients. the u.s. food and drug administration oversees the safety and labeling of all food products from plant sources, including those from genetically engineered crops. these products must meet the same safety requirements as foods from traditionally bred crops. the food and drug administration currently has a consultation process in place in which

developers of the underlying technologies address any outstanding safety or other regulatory issues with the agency prior to marketing their products. fda has completed approximately 100 of such consultations. no products have gone to market until fda's safety related questions have been resolved. according to fda commissioner margaret hamburg fda has, quote, not seen evidence of safety risk associated with genetically modified foods end quoit. further, fda has no basis for concluding that bio-engineered foods are different from other foods in any meaningful way and the world health organization has stated that, quote, no effects on human health have been shown as a result of consumption of such foods, end quote. in fact, they can grow faster

resist diseases and drought, lower reliance on pesticides cost less and prove more nutritious. even president obama has stated that, quote, advances in the jennetic engineering of plants has provided enormous benefits to american farmers. and that investment in enhanced biotechnology is anzkv essential component of the solution to some of our planet's most pressing agricultural problems end quote. nonetheless, there have recently been a number of state initiatives calling for the mandatory labeling of food products that contain gmos, and we'll hear today from a number of witnesses who can speak to such actions and the impact they'd have. food labelling is a matter of interstate commerce and is therefore clearly a federal issue that rightfully resides with congress and the fda.

i am concerned that a patchwork of 50 separate state labeling schemes would be impractical and unworkable. such a system would create confusion among consumers and result in higher prices and fewer options. foonlly, i want to commend mike pompeo and representative butterfield for their representation anesthes issues. i look forward to learning more about hr-4432 the safe and accurate food labeling act of 2014. and i would seek unanimous consent of the committee that mr. pompeo who is on the full committee be able to sit with us today in this hearing. without objection, so ordered. >> i'd like to thank all our witnesses for being here. i look forward to your testimony and at this time, i yield five minutes to the ranking member for his opening statement. >> thank you, chairman pitts.

today's topic is the thoughtful consideration of this committee. many americans are interested in the labeling foofds with genetically modified foods. it can lead reasonable people to different conclusions. for policymakers there are a number of considerations involved. we'rable to share a range of perspectives of an the issues and hope we can engage in an honest and respectful discussion. genetically modified foods have been in our food system for decades. over 70% of processed foods contain gmos. however, they are not labeled as such in the wake of growing concerns from consumers, the food and drug administration issued a policy statement an its regulatory oversight and labeling policies for gm foods in 1992 and in 2001 issued draft guidance on voluntary industry labeling. i fully understand why consumers want to know what goes into the food they serve their families,

for people to make informed decisions about what they eat, they need information. and that's why we require food labels to require nutrigss facts, they must use common rather than technical names for ingredients whenever possible so this information is, in fact useful. it's also why several states enacted their own regulations mandating theilabling of these foods. three states put new laws on their books while many more have considered doing so through ballot initiative or state legislation. none of the state label laws have gone into effect yet. while it gives voice to the many who are concerned i'm troubled by the net effect of the inconsistent state standards. the agricultural production and food distribution chains cross state lines and conflicting regulations could cause difficulties rurlting in higher costs for consumers. like the advances in medical technology, innovations in

biotechnology have a real chance to improve the quality of life for people across the globe. it's representatives of the american people that must make sure the application of these technology does not put consumers at risk and information is available for those seeking it out. science must reman the arbitter of any safety concerns and it must reflect a rigorous evaluation of the evidence. i'm glad we're having this hearing. i look forward to the panel's testimony and hope we can weigh the merits of all recommendations and evaluate just how any regulatory approach would best serve the interest of the american people. i'd like to yild the remainder of my time to the gentleman from north carolina, mr. butterfield. >> thank you, mr. pallone. thank you, mr. chairman and thank all of you for coming today. mr. chairman access to safe and affordable food is very important to every consumer in america. i think at least we can agree an that fact. i begin this conversation by saying that i represent an

agricultural district in north carolina. it is also a low-income district. and so i have a very keen interest in this subject. a large portion of my north carolina district is agriculture. farmers all across my state and across my district remind me that north carolina farmers don't just grow crops for north carolinians. they grow crops for america. and so the food supply chain is vast, interconnected. the work necessary to get an apple or ear of corn to the produce section at the supermarket is staggering from seed to farmer to wholesaler to processor, to packer, to distributor, even to the store shelf itself. it's easy to appreciate the intricate system that feeds america. and i'm beginning to learn more and more about this. but several states have proposed regulations and that i worry would cause significant disruption to the nation's food supply.

it would cause confusion and uncertainty among consumers and ultimately will result in increased cost at the checkout line depending on what regulations mandate separate supply chains would have to be developed beginning at the farm and every step all the way to the supermarket. the new infrastructure requirements are as daurnting as they are costly. you can bettal of those costs will be passed on to the'8bqk consumer. studies showing the average cost topping $500 a year. for many of my constituents, that would be impossible. i worked with my friend mr. pompeo to propose what is a measured approach that gives consumers certainty while taking into account the delicate balance and sheer size and complexity of the food supply chain that employs many americans. the proposal is very simple. the fda, our foremost food safety authority, should have the authority to require labeling an genetically modified

foods and establish federal standards so that consumers regardless of where they live or work will clearly understand the options. finally, mr. chairman i will be the first to say that this proposal is not perfect. this proposal is not perfect. it will certainly evolve as it progresses. we don't legislate in a vacuum. but i believe a national -- a national labeling standard makes the most sense for our highly integrated and interdependent food supply. i'm confident we'd tack what we learn from today's hearing and the input we're sure to receive to inform our work as we move forward. we need common sense legislation. thank you very much. >> time has expird. the chair recognizing the vice chairman chairman, gentle lady from tennessee, ms. blackman for an opening statement. >> thank you, mr. chairman. the people who are going to be harmed the most by the anti-gmo

activist movement are those who can least fight against it. for example there is a rice. it's called golden rice, which was developed with genetic engineering. one of the benefits to this rice and the reason golden rice is that it has a level of vitamin a that is not found in other rice. golden rice has fed millions of starving people around the world and additionally prevented blindness and death because of the presence of vitamin a. the vice rhys has been scion to be safe by multiple tests and yet the anti-gmo activists have opposed its use because they don't like genetically modified food. farmers have jennetically modified food for centuries. farmers woulb get the best traits. crops were developed which are most resistant to drought pest and weeds. george washington carver did research and taught at tuskegee

for over 40 years. while there, he developed techniques to improve soil give farmers alternative cash crops, improve the nutrition of people living in the south. he did this by experimenting with different varieties of peanuts and sweet potatoes. of course, different varieties are simply products with different genetic makeup. to bring reason to this discussion of different varieties of food my colleagues and i have introduced hr-4422 the safe and accurate food labeling act of 2014 introduced by rep pompeo and myself along with matheson and whitfield would prohibit genetically modified plants intended for food use to be soiled without first 03$:mcomplying with the safety review process at the fda. under this bill if the fda were to find a difference between the new product and the comparable

non-gmo food that might affect safety, the fda would require a label. the bill would do the following. advance food safety. address the questions that consumers have about the safety of gmo food by requiring the fda to conduct a safety review of all new gmo traits before they are introducedrd to the marketplace. inform consumers. help consumers make sense of gmo labeling claims and their choices in the marketplace by asking the fda to establish federal standards for companies that's want to voluntarily label their product for the absence of or the presence of gmo food ingredients. number three provide consistency. improve food labels using the term natural by requiring fda to define the term for its use on food and beverage products thus creating a consistent legal framework to guide food labels

and inform consumer choice. fourth,fqxñ eliminate confusion which is what's all good legislation should do. and remove the uncertainty of the 50-state patchwork. thank you for holding the hearing. at this time i yield my remaining time to mr. pompeo. >> thank you for yielding. thank you to you and to mr. butterfield for being co-sponsors. you can see that we're engaged in a bipartisan effort to get to the facts and science surrounding this incredibly important issue. i want to thank all the witnesses. especially stacey, a fellow kansan. on behalf of consumers across the country, thank you for being here. at the end of the day, this is a bill needed to make sure that folks across america can afford food. we in america have known for a long time that absent innovation and technology, the food prices will rise dramatically.

we won't be able to feed the next billion people in the world either something we take great pride in. studies have shown absent this legislation, the average family's food bill will go up $500. while for some that is not a lot of money, there's a lot of folks i represent for whom that's an awful lot of money and they are living day-to-day and paycheck to paycheck and make sure their food prices one of the things they have tow!ñfe hard decisions about, doesn't get more difficult in this economy that is struggling so much. it's also to help folks who are the producers of this food. to make sure that they have a way to get this product from their cattle ranch or farm or wherever it may be to our store shelves in a way they can do profitably so they continue to invest in their products so america continues to be a leader in world production of food in an affordable way. the science is not debatable here. there have been lots of research, lots of studies.

those who oppose the bill don't make a lot of case about the science. that's what fda is all about. getting the science right. this bill gives them the toont to review(g$m that. it's really good policy and will make our food splay chain enviable all around the world. i yield back. >> i recognize the ranking member of the full committee, mr. waxman. >> thank you, mr. chairman. today's hearing is on a topic about which many americans have strong feelings. 20 years ago the first slow ripening flavor saver tomato went on the market. today the vast majority of corn and soybeans and canola and sugar beans and papaya grown in the u.s. are genetically engineered. they have been assessed by the food and drug administration in a voluntary consultation process, and fda has found no

significant differences between them and their traditionally bred counterparts. some 70% to 80% of packaged foods contain ingredients from genetically engineered or ge plants. yet despite their ubig withy and fda's okay, many consumers remain uncomfortable with these foods and want mandatory labeling so they can avoid them. as we consider the questions on ge foods at today's hearing, i'll examine them in the context some of important principles i have long supported. first, i believe it is critical that our actions be based on science. as with so many other matters pertaining to products why use and consume every day, we need to rely an the expertise of fda and other scientific regulatory agencies. second, when we consider requiring labeling on food that label should provide useful

science-based information to consumers. i certainly believe that food labels should enable consumers to make informed choices. i fought hard to pass legislation that gave consumers useful information about the nutritional content of food. there's a compelling reason otherwise, we should man tain the ability of states to make a decision that is different from the federal government. all three of these concepts are in play here today and i think we should examine each carefully. on the first concept, what does the science tell us about ge foods? from what i understand genetic engineering is not an inherently dangerous technology. certainly when it is used to give new properties to plants we need to make insure those new properties don't affect the safety or nutrition from those plants but if fda has done that

and finds that ge food does not differ in any significant way from traditional food, why should there be a label that marks it as different? if there are safety questions about a food then it shouldn't be allowed on the market at all. i look forward to hearing more from fda and other witnessesógaxñ on this today. nevertheless, i understand that people may still want information about how their foods are produced. so let's look at the second concept of whether there is a way to give them meaningful and useful science-based information. on the one hand, i'm concerned that people have the information they want or need. on the other hand, i'm concerned that mandatory ge labeling could be inherently misleading. mandatory labeling could lead consumers to believe that if the government is requiring a ge label, it must mean that ge

foods are riskier or somehow fundamentally different from non-ge foods. and to date, scientists have concluded that they are not. furthermore, given that up to 80% of packaged foods contain ge ingredients, if we require labels, most food on the shelves would have a label declaring the presence of ge ingredients. i'm not sure what good that does us. under the current system if consumers want to avoid ge foods, they can. they can buy organic foods which, by law, cannot contain ge ingredients. or they can search out the foods that manufacturers have certified and labeled as non-ge. that more targeted information may in fact, be more usable, and i'd like to hear what our witnesses think about that. now let's turn to the third principle of preserving the ability of states to make decisions that are right for

their citizens. absent a compelling policy reason to the contrary. even if there's not a compelling reason to require ge labeling at the federal level that doesn't necessarily mean congress should tell vermont and other states that they cannot require such labeling. i always believe states should have the right to act in the best interest of their residents, and i want to hear from our industry witnesses why the vermont legislation and potentially similar legislation in other states is so harmful to some legitimate public interest that congress should override them. absent an compelling reason, i support letting states make their own laws and govern themselves. i remain open to hearing the views of all of our witnesses today on these three points and then the other points pertaining to this issue. i think today's hearing will be very interesting and informative, and i thank the chaurm chairman for holding it.

>> that concludes the opening statements of the members. the written opening statements of the members will be made a part of the record. i have unanimous consent request here, a statement from the corn refiners association to enter into the record. without objection, so ordered. we have two panels today. i'd like to call our first panel. and i'll introduce at this time. mr. michael landa, director, center for food safety and applied nutrition of the u.s. food and drug administration. thank you for coming today. you will have five minutes to summarize your testimony your written testimony will be placed in the record. so at this point you are recognized for five minutes for your summary. >> good morning, chairman pitts, ranking member pallone and members of the subcommittee. i'm michael m. landa, director

of the center for food safety and applied nutrition at the food and drug administration. thank you for the toonts to be here today to discuss fda's regulatory program for jennetically engine ired or ge foods. over the last 20 years fda's reviewed data and information on more than 150 plant derived ge foods. these range from herbicide tolerant soybeans to canola oil with a modified fatty acid profile. based an our evaluations, we are confident that the ge foods in the u.s. marketplace today are as safe as their conhaven'tionally bred counterparts. the improvement of plants has been going an for thousands of years. >> could you pull the mike a little closer to you? >> sorry. is that better? >> that's better. thank you. >> typically, plant breeding has involved cross breeding and hybridization. many of the foods already common in our diet such as hybrid corn or nectarines are derived from

plabt variety using conventional genetic techniques. during the breeding process, undesirable traits sump as poor yield or poor disease traits. they can often be eliminated through additional breeding and selective reproduction but the process is painstaking and time consuming. today by inserting one or more specific genes into a plant scientists are able to produce a plant with new advantageous characteristics. these techniques give scientists the ability to isolate specific genes of interest and introduce them and their corresponding traits into plants without introducing undesirable genes or traits. this important improvement over traditional plant breeding can reduce thef áát needed to develop a new variety and expand the range of new proteins and other substances that can be introduced into plants. any of these genetic

modification techniques has the ability to"% food. fda, established scientific procedures for evaluating the safety of new foods including any new substances in food, and our guidelines help developers address any safety concerns prior to marketing. fda regulates the safety of all foods, including those derived from ge plants under the federal food drug and cosmetic act. foods developed from genetically engineered plant8÷qb varieties such as fruits vegetables, grains and their byproducts are subject to the same safety requirements as foods derived from lk plants. the agency relies primarily an two sections of the food and drug act to ensure the safety of food and food ingredients bruce prooused by genetic engineering.

food growers, manufacturers and distributors are responsible for taking the steps necessary to ensure their food products are safe. the law places primarily responsible for ensuring safety of food an industry. to help developers derived from ge plants and fda's regulations#fiñ the agency encourages them to particinate a voluntarily consultation process prior to commercial distribution. since the process was created, developers completed the process more than 100 times as they sought to introduce plants?!vx into the u.s. market. typically the consultation begins nearly development when the agency advises the company an what tests would be appropriate to assess the safety of the new food. after the studies are completed a summary of the data reflecting safety and nutritional assessment provided to fda for its review. fda expects developers of ge

foods to analyze the composition of the foods from their new crop varieties to ensure that any changes compared to the foods geneticallyea) as part of our review and analysis we look at whether any newly introduced protein is allergenic or toxing and nutrients or anti-nutrients have been changed in any way. we knrrdz considers premarket approval. examples to the information evaluated include the name of the food and the crop from which it's derived.f'say the source, identityies and functions of introduced genetic material. the purpose of $ the modification and suspected effect on th%khr characteristics of the food. the identity of any new substances introduced. a comparison with the composition and characteristics to that of foodom derived from the parental variety and information on whether the genetic

modification alters the allergic or toxic potential of the food. let me speak for a minute or so about fda regulation ofqú=>s labeling. we regulate labeling, including labelling of ge foods. the act establishes the food is misbranded if its labelling is false or misleading in any particular. the act also provides that labeling is 1 one, fails to reveal material facts that are material with respect to representations made or suggested in the labeling. or, two fails to reveal facts that are material with respect to consequences that may result from use of the food, whether that's a labeled use or customary use. the use of jennetic engineering in the development of food is normally not by itself material information within the meaning of the food5@fqw drug act. federal courts have held it

absent a material fact. the act does not require labeling, indicating the food has been developed through genetuc engineering. in closing let me reiterate the consultation process for foods derived from ge plants is working well. and provides for a rigorous food safety evaluation of such foods. the agency will be vig lent in ensuring the safety and integrity of the food supply. >> the chair thanks the gentlemen. we'll begin questioning. i'll recognize five minutes. mr. landa you state in your testimony that fda has reviewed and evaluated data and information on over 150 genetically engineered foods. data compiled offer the past 20 years, is 9wñ the agency more or less confident today in> safety of the underlying

technology? >> its confidence remans strong. has been and remains strong. >> how do you know that genetically engineered foods are no different in terms of safety than their conhaven'tional counterparts. >> we know this based on the reviews we condcts. looking at the genetic material, products of that material, new proteins, for example. at their safety.,3=ur(t&háhp &hc% we look at toxicity, potential toxicity. allergenicity, chemical composition to see whether it's difference from the conventional counterpart. we look at the safety of the whole food if you will. and we look to see whether there are any differences in nutrients. that might require disclosure for example. >> how long typically does your

evaluation take? >> i will have to get back to you with detailed information if i may. >> all right. are there any material differences between genetically engineered ingredients and those derived from traditionally red crops? >> in general, no. we have found there have not been such differences. >> does the fda support the various state legislative and ballot measures that

they'd interfere or not. >> would state specific labeling requirementspkq& change anything as far as your evaluation is concerned? >> i do not believe so. >> all right. let me ask if there currently is a lack of consensus about the validity of the research and science behind the safety of foods derived from genetically produced. >> there is not. there is a consensus. >> there is a consensus in the scientific community? all right. this time i will recognize mr. ÷

pallone. five u(aáwqj for his questions. >> thank you, mr. chairman. mr. landa. who oppose mandatory ge labeling argue it would be inherrantly misleading. they argue such a requirement would easily be taken to imply the government considered food from ge plants to be so fundamentally different from food from non-ge plants as to warrant a special designation. i guess i agree if the ge designation had to look look a warning it would be misleading. hover in the next panel, mr. favor testifies his association not asking for anything luke a warning label but rather a modest disclosure on the back of the package. i guess i'd like to get your view, whether it would be possible to design the size and wording of a mandatory ge designation in order to be inocuous. those who look for it could

foond it. those who don't care about it would have no reason ton qbc(ay attention to it. i'm not asking whether fda could require such a label, nor whether you think any form of(e4y mandatory ge labeling. but whether totx[4 avoid labeling requirements would to be impose a federal ge labeling requirement. do you think it would be possible to do so in a way that would be"" neutral and not tarnish the product and also, if you could describe fda's experience with eradiation labeling and÷5 whether we can learn from that experience? i certainly have not thought about the question you posed with respect to the nature of a statement about ge labeling. i don't think the agency has considered that. our focus has been on whether

there's been a difference -- >> the material definition. >> allowing us to require disclosure. i think one way of looking at that question is whether there are data on similar efforts or whether one could sdoondesign a study to answer that question so that people would look at different formulations of labeling and you would learn what they would take away from those different formulations. >> the reason i ask the question, i just/oj% don't feel you can answer it at this point. a lot of people approach me that would like a labeling requirement don't necessarily make the argument there's a scientific difference but just that -- or that it's bad but just that" >> no i understand. but one might for example, again, maybe one could develop different formulations and do experimental studies surrounding

them. the types of studies that are typically done over the internet with panels that are set up. large numbers to see what people would take away from a different block label. >> you say the fda's consultation process is, obviously, right now voluntary. but what does that mean in practice? if it's voluntary why would companies choose to use it? do you have an estimate of how many manufacturers choose not to' use it? what's the pros and cons of this? >> we think for people intending to commercialize product we think those people do come to us for several reasons. one, there's the basic statutory requirement on companies to market food that is safe. another is that we learn a great deal from epa and from aphis and others about what is going on in

this area, which is another incentive for people also to come to us. and finally we think that growers are going to be/kfq reluctant to use seeds where there isn't a sort of no questions letter from us because if at the end of that growing season they have a crop that turns out to be either unlawful o2k(99 marketable because questions have arisen, better to start with a product that's been through the consultation process. so we think there are lots of drivers that make the voluntary process one people do subscribe to at least people intending to commercialize. >> you say that the fda hasn't required the genetically engineered label because they don't believe the information is material. does fda have the authority under the act to change its assessment that information is not material?

authority to do that? >> yes certainly in the given case. let me alsoeq been describing, we've been discussing, has been in place for roughly 20 years. but we've been asked to change it. we have before us several citizen petitions asking to change our view on the law with respect to materiality and asking us to change our view with respect in some cases, to the facts. and petitions. we haven't responded yet. but we certainly have the authority to change a position as long as the change is appropriately grounded in the science and interpretation of the law. >> thank you. thank you, mr. chairman. >> the chair thanks the gentleman. >> thank you so much for your time. i have to tell you, i find this an absolutely fascinating debate.

take the time and the fda would take the time to talk with us on it. i grew up in south mississippi with a grandmother who, when she>a7t went to college at the turn of the century, the 19th century chose to audit agriculture classes. so then buying a farm and with her savings from beingbh a teacher. and married. sheq70tx has five boys from -- and then my mother, five more boys. big farm. during the depression, she helps feed our hometown. so being someone who enjoys growing things as i was, and very -- appreciate what goes into having good looking food because we eat with our eyes. i also grew to appreciate yield per acre that i would learn from

my grandmother. and having foods that would be more drought resistant, that would take&;qxz less chemicals that would take less pesticides things of that nature. and the importance of that so that you had a good-looking and good-tasting food product that did not readily and5 easily spoil. so i come to this debate from that background. and today, even in my district, i visit a lot of the farmers markets, and every once in a while someone will come up and talk about genetically engineered food or john etically modified food. and i enjoy asking them what that means to them. and i have found it's so fascinating that it means everyone that i talk to. because we don't have that federal standard, if you will and i hope that you all with the

fda are going to be able to work with us on this. basically, everything we eat is genetically modified, whether it's corn or wheat or any variety of tomatoes which were mentioned earlier. it all has been genetically modified. if you want to go back and eat original wheat or barley, it's not going to give you very much of a yield and it's not going to be the desirable product that you're looking for today. so we have toe part of this debate. so moving forward let's go back to the question on the labelling. i'd love to hear from you what you all at the fda, what your team thinks should be in had those labels to the consumer. what should be there about health about safety and about nutritional content of those

products? >> well, the statute tells us as a general matter that labeling is not to be false or misleading. that's some of the basic proposition. and since then there havev9 many changes to law including an lea which has directed us to write then the nutrition facts label which has information about macro nutrients and micro newt rents. in we're in the process of updating that label. and we're reviewing comments on it. >> and when do you having those6>x recommendations? >> i would certainly hope the agency could issue final rules updating0[ nutrition facts by 2016.

it's a complicated -- it's called informal rule making which is less difficult than formal rule making but it still a very resource-intentionseive process. >> i'm certain you all go through reams of information on analyzing data on the ge foods, and i wonder how often do your fda analysts go back and request ctr(t&háhp &hc% additional information when you have a submission? >> i don't know.8ñ i can't answer that. but we will get that information for you. >> okay. does the fda distinguish foods)çaç based on thekbj method of breeding or the material composition of |food? unless there's a material fact. >> okay. are you satisfied that your agency is capable of understanding genetic engineering and determining whether or not a plant is safe? >> yes. >> thank you. i yield back. >> now recognize the ranking

member of the full five minutes for questions. >> thank you mr. chairman. mr. landa, in many of the claim that the science is unsettled, controversial or new, with the implication that theref5 may be unknown risks and therefore consumers are justified in being uneasy with ge foods, and yet, from your testimony we get a different impression. however, while you point out that genetic engineering is just one of many techniques used in plant°bz breeding i don't think fda has a consultation process for any of the others. foods, and what are the risks from them and if genetic engineering is not especially risky, why do you companies to go through your consultation process prior to marketing foods from ge plants? >> ibi ñ think it's largely a, there

certainly is some possibility of for example of a material difference. i think we identified one with a product where there wasn't a safety issue but there was a difference in how the food performed in the consumer's hands. i think it had to do with friability. and we have completed over 9i7&l consultations. there have been a handful that have not gone to completion. where we were asked just to stop withdrew. i think, in general the process, which has been in place for some time, was one that enabled us to learn and also to build confidence, and we would hope to transmit some confidence

in thisjpr technology. >> is this a new new area3jfut of science? >> no. i mean certainly it's decades old. >> as you know, many consumers believe they have a right to know whether a food was manufactured using genetically engineered ingredients irrespective of all the science in the world showing them to be no different from non-ge ingredients. i'd like to understand more about such a requirement and how it would fit in with fda's traditional stance toward labeling requirements if congress were to respond to this consumer demand and pass a law requiring the labeling of genetically engineered foods. how would mandatory labeling of genetically engineered foods compare with existing labeling requirements, such as to reveal the presence of allergens in a food or that a food has been irradiated. would fda be concerned about a

new law that requires labeling of ge foods? and if so, why? >> there isn't any administration position on any, on such legislation. it would be obviously, new for us. we would implement it as best we could. i suppose the question itmw"> for safety reasons. >> to keep the food from spoiling?

? example. >> is2h[[here any harm to that? any consequences that are problematic? >> no. >> yet we require labeling. why do we require labeling on irradiated food? >> it has been thought thatwfñ irradiation could, as a process could change some properties of the food and also and so that was the thinking behind that. >> but there's that. >> i'd have to go look at the time what we said at the time we issued the labeling requirement. ? now why is this any different? you don't think there's a problem. you said there may be a problem but you don't know of a problem. what's the difference between informing people that their spices have been irradiated if they want to know that information, even though you don't think it's technicallyparticularly helpful for them to know it. >> as i said, at the time hi think there was a possibility of

a change of characteristics of the food, which people would not know about. we do not think that is the case with genetic engineering. >> do you think we should remove the labels from the irradiated foods? ? the agency has issued a proposal to do that. it has not finalized it. >> thank you. >> recognize the gentleman from illinois for five minutes for questions. >> thank you,:my mr. chairman. thank you for being here.(kqr the question i have is of of,.3qó i understand this debate. do you know of any state that has theú h capability to do the research and the findings to the samevtf6 >> i don't but i wouldn't have any reason to know that one way or the other.

>> i can tell you, i'm from the big state of illinois and we can't do it. there may be one maybe california has some ) dlrcapability, but my guess is, smaller statesívwpñcpr they don't have nearly the ability to do the research that you all do and i think that's part of this whole, should states be ableuáb=s to have their own labeling restrictions and requirements because as we found, it's really based upon emotions and not based upon a scientific evaluation. let me let me ask distension western foods based upon the method of> we don't require labeling based on method of production alone. >> why not?

>> because we have found that it is not material to safety or nutritional composition. >> and appreciate that. let me in the case of sugar. right? we, sugar processors require to label whether refined table sugar comes from i guess the question is, are sugarw km processors required to label whether refined table sugar comes from a certain species or plant? ? i'm sorry i don't -- >> you don't require fine table sugar to label whether it comes from sugar beets or from cane. >> no. >> why? >> again, i think it's a question of materiality.

>> would consumers be rkykçany, would they get any benefit if that labeling requirement for fine table sugar also had a requirement, well tiie is beet produced fine table sugar or sugar cane fine table sugar? >> again, what we focus on is the attribute of the food at consumer we think would eat it. >> for the genetically engineered ingredients in foods today, is there any evidence that they vary in their objective characteristics in any meaningful or uniform way? >> no. not as a class. >> can you explain why fda's regulatory focus is on the food or food product as opposed to the process in which itqoñ was grown. >> of course, in the end it's thec >> right. yeah, and i appreciate it.

i think you're going to keep getting the same questions from members here on trying to understand, you are, food and drug administration you all come before u36 d on a lot of different aspects. you are our trusted advisers. we respect the job that you do. i know that this is6hñ a veryh; l difficult, emotional dough moegsmotional debate for some folks on both sides, because it deals with individual consumers, the agricultural represent. we have to have an impartial you know observer based upon health and safety effects to the consuming public. we appreciate the work you do. mr. chairman, thank you. and]ee >> the chair now recognizes the gentle lady. >> thank you for your appearance here today and your testimony. i understand that fda's position, that under the food,

drug and cosmetic act, the breeding methods by which a plant is developed is not material information about food from that7 however, in theirzn!wñ testimony,= d mr. faber and representative webb pointed out that many consumers do believe that foods labeled as natural, end quote, natural are not genetically engineered and sometimes buy such foods because of that belief. they also say that many such ay7pfoods do contain ge ingredients. i can understand fda's reluctance to wade into the argument into what constitutes natural. but if many consumers are led to believe that natural means non-ge and tp÷28 make purchases on that belief shouldn't the use of that term on a food label represent that the food is non-ge? i know that's packed quest7

i'm going to continue for a little bit more. give you plenty to deal with. that's my only question, actually. and if so wouldn't the term of the use natural on a food containing ge ingredients be, as the statute says, failing to3 reveal facts material in lighttyv2 of such misrepresentation if it does not state that it contains ge ingredients? it gets convoluted. in other words, and this is the question. even though the use of genetic engineering may not be material information per se doesn't it become material information in those circumstances in which the rest of the labeling of the ge food implies that the food does notuu contain ge ingredients? if you can sort that out, kudos to you. this is a topic in which i wish to hear from you. and take your time. >> there is a short answer to this. which is thatú=4c we have pending several citizen petitions

related ip= the question of what is natural including one going to the very question i think yo the food that contains a genetically engineered ingredient or ingredient derived from a genetically engineered plant a food that may properly be labeled as natural. there's a debate about that. we have been petitioned tom,:o say yes. i'm surelb,.p we've been petitioned to say no. we've been petitioned to establish a definition for natural, and we are considering those, those petitions. it's really all i can say at the moment. >> is there any, can you shed any light on this topic for the sake of our constituents as to where you]hfr are going in your, i mean, i agree, it's very confusing. >> well, i, one possibility we

have not committed to this but to take you back a9f; little bit, the agency embarked on an effort to define natural years ago that did not result in a codified definition. it resulted in a statement yn÷u the preamble that natural can'tqgfzsx0 be either aided or sipen synthetic i think was the definition. we've always said we don't have the resources to do that. we now have petitions beforel i think, if we decide to reconsider this issue it will, it will necessarily have to be a public process. whether we would embark on rule making, which has to be a public process or guidance there will be some public process if we decide to revisyk,l this. >> i actually applaud that.t,ñ i think the public is already engaged. i believe that, and would be a welcoming, this is pie opinion now, but from what my constituents are telling he that they are already engaged

and single from fda, that maybe you don't have plaqueblack and white answers to give, that you are considering this and maybe we can carry down this conversation afthroughout the country. it añ÷ appears to me the consumers are confused by the current labeling system. we can all agree on that. it's complicated today. and they're making purchasing decisions sometimes on unclear labelivs"3o cf1 o and it leads to a state ofç confusion. and i hope that you can find theóí÷ resources in fda to take a broader look at what is happening with respect to&y.ñ consumers' experiences so that they can have confidence in this system that we have and work with you to strengthen the

labeling system to reduce the kind of confusion that we're talking about. with that i'll yield back. thank you. " p'k you. >> the chair thanks the gentle lady. >> i eat a number of odd foods, and a number of them are labeled non-gee non-gmo. is there a difference? >> i think as a technical matter, gmo refers to anq]ye genetic organism as opposed to genetic engineering which we think of having to do with modern biotechnology. >> i come from a family where just about half of us have some kind of food allergy. if you're changing pro deeps around and you have things that

recognized as safe, generally recognized as safe are you able in what you allz&ñq do to be able to distinguish a protein that someone may be allergic to has been added to)ñ&=ñ a product which they may not know that protein's just &a2included. >> that is part of the evaluation process. and if there were to be an addition, it might prompt an allergic reaction that one would not expect, we would require a label disclosure. >> so you'd pick out those things which people are highly allergic to or which there's a significant percentage of folks that would have a pro< it. you'd say okay, you can't put the strawberry ingredient into this. >> or we would require a >> disclosure. >> most likely would be the -- >> and i apologize if i missed this inb b answers. are you all looking at the possibility of for those people

who may be concerned, saying or labelling a product as something that is in fact, as opposed tome9ú saying it is genetically engineered or genetically those companies that want to, obviously you pay more for it, but have some process where they can actually say, we've used all products that are not jen et ceteraically engineered or modified? >> we've had draft guidance sense about 2001 on voluntary labeling. so there aren't any prohibition on a volumen tear nvoluntary label that your food does not contain ge ingredients, not to be false or misleading. >> appreciate that. you indicated earlier that this was a consensus that this was not something dangerous ifb] i understand your testimony correctly, and yet i know there are a number of countries around the world who have concerns about products and will ban our

products if they think there's been cross-pollination or something. yi concerned? >> i think d)wpvuju countries have different regulatory systems. there are obviou= different cultures with different attitudes towards different aspects of foods, from production to consumption to preparation and everything else. >> other than culture have any of those countries had studies that indicated there was some danger to the human? >> not tojs÷ highmy knowledge, no. >> appreciate that. and i think you said earlier you're looking at finalizing some guidancex tñ by 2016? >> the nutrition facts. >> yes, sir. >> yes. >> and i'm going to switch briefly because we have a little bit of time left, to a different subject, and that is what do you do about the grocery stores fixing food and doing things and they've got to y nutrition

facts, and then you get into the whole allergens and then the ge or gmo foods? how do you deal with that as a part for grocery stores?óz >> the processed food is subject to nutrition facts. what we have called restaurant-type food made and sold in a grossry store is now subject to or will be when it becomescí$ effective, to labeling requirements. >> i think i would just tell you, i think that even though i'm concerned about it and i might not eat the food ifsifs i didn't know what was in it, i'm not sure how a grocery store's going to be able to comply with that when they may be using all kinds of ingredient and somebodyzaw, cf1 o walks up and says can i have x y, or z. the grocery store may not have that capability. >> we're talking about standard ÷n(u items. >> so if it's some kind of

specialty item they would have an exemption? >> the requie3hzt is 20 or more retail establishments and it's standa >> thank you very much. i yield back. >> recognize the gentleman, mr. butterfield for five]x minutes of questions. >> let me just, the statement by ms. blackman about this being a fascinating debate. in my former life, i served as a trial judge in north carolina. and every day for 15 years,ly to look at the evidence and had to decide the facts. that was my job description and i did it for 15 years. and i've tried to do that in this debate, and i've read harm amounts of well-informed publications over the last several months. and i, for one i'm just convinced that ge plants are as

safe as any other foods. but mr. landa, i need to ents pose this question to you. do your6:yr have any evidence that foods derived from ge plants are i've heard you mention it throughout your testimony but is there any:ywsáilla of evidence that would suggest that these foods are unsafe? >> i want to make sure i heard you correctly. is there any evidence that suggests that these foods are unsafe? ? >> yes, yes. that ge foods are unsafe. >> not to our knowledge no. >> and how large ii(s your agency? how large is the division that handles this task? >> well, the office that handles that task has maybe 135 or 140 people. but certainly it is recognized as safe substances.

>> these are not politicians. these are career employees at your agency. >> correct. >> have youl+ anyone who advocates a 50-state'lidn approach to mandatory( >> not sure i -- >> i mean, you've talked to a lot of people, both form informally about this. >> any one who advocates that we have 50 separate -- >> 50 sets of regulations, plus the district of columbia? >> i have not had reason to encounter such a person. >> itn ill logical, and i'mf@h wrong sometimes, but i don't see how that would work even in california. i yield f]h >> chair thanks the nazqgentleman. the chair recognizes the jeptsle lady from illinois. >> thank you, mr. chairman.

i'm trying to sort out the science here.)g i have lots of passionate constituents who are very concerned about ge products. i have experts that we'll hear on the next panel who have great scientific credentials themselves who will argue about consumer information being provided about ge products. i want to follow up on another word ms. caps was talking about i want to ask you about material difference. and you said that the fda could change the view that ge status of food is not material, which it is, that's the position[çd&p right now, there's no material difference. and that the agency is evaluating citizens' petitions that report to do that.?t so, can you elaborate on why the

fda has not believed this is a material difference and what has the court said anything about it? what kind of different information might change your mind? >> well differences in relation to safety oré composition or again, as it considering these foods as a class, any differences in safety or nutritional composition or any other attribute of the food. ? can >> can i ask you one thing? what about food allergies. accept we're putting into the dna, perhaps from a peanut into something else. >> in that case we would require a disclosure. that would be material. >> and would that prevent in this consultation process from that particular formulation goingñ to market? >> no. what would happen is therel"&would be a disclosure of the allergic

potential of the food. that would be a material fact. >> okay. and i know mr. pitts said youvjp% can use less ] ypesticide that'srp6pbtr(t&háhp &hc% sometimes true. although the fda has approved use of a seed that would make it a lot more tolerant of pesticides. does the fda have any concerns about that? >> i'm not familiar with that matter. >> 24 d and glies fate. okay. so material>o4@ meaning, even in the peanut issue then a disclosure would be required because of #nm/vñ >> typically, with respect to allergens, yes, that's, first of all, there's a statute 2004

statute requires disclosure of the, sort of we call theú2ñç5(pr(t&háhp &hc% eight allergens. but if you were to find another allergen, typically, we would require a disclosure of it rather than ban the food. >> and who does the research? i have to tell you, my constituents who are against gmos will say monsanto, dupont and, you know, can we really trust these companies thatncvpñ benefit so much? >> the data that are supplied to us are supplied to us by the companies doing the consulting. and they will do sometimes they will do the studies. sometimes they will pay to have the studies done. i will say that is true across all >- ñfda-regulated products. fda does research, but it

support voluntary submissions, much less marketing applications. >> let he ask one, one more question. does the food and drug administration have the authority to implement a!aay mandatory pre-market approval process to, of any food to ensure that it's safe for consumers? >> we proposed a number of years ago a mandatory notification? ÷ program for the typesnhñ of products we've been talking about this morning. that proposed rule is still in existence. we have not found the need to finalize it given what we think is how well the voluntary program 7) but that proposal necessarily maintained that we had the authority to establish a mandatory

>> and in the, i'll yield back. i can put some more questions in writing. thank you. >> chair, just for clarification, when you say it6 t requires disclosure does that mean -- on the label? >> on the label. yes. thank you for that question.(@xó>> thank you. mr. madison is recognized for five minutes for questions. >> thanks mr. chair-and mr. landa, appreciate you coming here today. you just said this with mr. butterfield, but i want to be clear. from the fda perspective, to date you've found no scientific evidence that there's a health and safety issue with genetically engineered foods. >> that is correct. >> thank you. appreciate that. if there is this consumer demand for wanting to know if there is a producer of a non-gch much o food? the organic industry they can label their product as such that it's non-gmo correct? >> so long as the labelling is

not false or misleading, that's correct. >> so if the marketplace wants this, there is a way for natural foods to do >> that is correct. >> does the fda regulatory have any authority over that type of labelling? >> it's the general authority that labeling must not be false or misleading. >> how long has the fda been involved in managing food labelling? >> "áwell, the provision the false or misleading provision dates from either 1936 or ''i,ebrñ >> we'll stipulate it's a long time. and how is the fda's role in terms of if i'm in the food industry, and there are a lot of different people in it how does the fda's role give signals to the food industry in how to do labelling? they look to you for guidance

and consistency is that correct? >> correct. they look to guidance we issue, and they certainly, when they have particular questions companies will call our experts in labeling. >> so how do your guidances work? how do you come up with those labeling guidances, and how do they work? >> typically. on a significant issue we would issue what's called the draft guidance. we would call for comments on t we would analyze the comments we receive and issue it in+d÷t5c&@ final with or without changes or perhaps decide not to issue it at all. >> and the food industry relies on that. that's where they get their direction for how they do labeling is through your guidances. >> first the statute then the regulations, and then guidance yes. >> how do food manufacturers -- about a national system versus a

50-state patchwork system. how do food manufacturers from the big guys to the little guys how dohr!jítk benefit from a national system? >> there's a benefit to uniformity, i think the answer is they will, they're better positioned to tell you how much of a benefit that is to them. >> how do consumers benefit from a national system compared to 50 dig6wq't sets of rules around our country? >> i -- you see the same labeling for the seam product. >> there you go. people do cross state lines don't they? i go 2,000 miles every week back and áq10ñforth. so i think i would suggest -- not to answer for you -- that you're going to confuse consumers if you have 50 different standards. that would be my suggestion.

let me ask you a question. how, how would a, how do you and the fda resolve a situation if abzlt product is mislabeled. what do÷n6ir you do if some manufacturer mislabels a product? >> typically we would, we might call the manufacturer. we might issue what's called a warning letter. >> mm-hm. >> i4depending on how serious we thought the infraction was. if the label were not corrected ultimately, we can through thebo united states department of justice, seize the product that's misbranded because of a misleading label. we can enjoin further distribution distribution. >> you just defined the tools in the toolbox you have to address situations that are mislabeled. that's what i would suggest. you have been the fda, there

have been claims by some consumer groups that the 6clfufda is too closely aligned with the industry and it can't be trusted. how would you respond to that criticism? >> i've been in fda for almost 30 years. i work with people who have been there much longer, by the way. i think, i believe and my colleagues believe that we are civil servants. but that we are engaged in an honorable profession in an honorable activity. that does not mean we get every decision right any more than anyone on the planet gets every(ó r(t&háhp &hc% decision right. but we try to make decisions to the best of our ability, based on what the science tells us and based on the law and regulations and sound policy. >> mr. landa, appreciate the answer, and i thank you for your civil service. i think there are a lot of folks engaged in these that are trying to do the right things.

appreciate your forthrightness. >> chair recognizes mr. green for five minutes of questions. >> thankç!,r you, mr. chair and to our ensuring the health and safety of my constituents is always a top priority. and we hope™"'z to understand the role that bioenginñ in our economy. thank you for taking the time to be here, and we appreciate your 30 years of service to the fda. ilmb find this issue often leads to passionate claims. i6 hope your years at the fda can shed some light on the genetically modified organisms. how many plants are reviewed by the fda each year and how much team does it take to conduct those reviews? >>,ka we'll have to get back to you on that. the numberba h:< $á is about now, i think 103.

i think in five cases submissions were withdrawn or people asked us to cease the review. but we'll have to get back to you on yearly figures and average times. >> do you believe changing from the voluntary review the,e mandatory reviews would change the number of reviews performed by the fda each year? >> i don't know, but i don't see why it would. >> a coordinated framework was developed by the white house science and technology. the federal agencies like the fda, in the 30 years that the agency has been part of this, are you satisfied that your agency is capable of understanding genet eck engineering in determining whether or not a plant is safe? >> yes. >> dolk you feel the fda has the staff and capabilities to be4agn the voice of authority when it comes to gmo safety? >> in connection with foods in my center, yes.

>> food safety. do you feel that the coordinated framework provides adequate safeguards for consumer safety and gives companies the confidence they need to develop new products? ? yes. safe. >> i'm sorry? >> has a bed gmo plant been deemed unsafe in the past volumen terry review processes? >> not k that i'mzd ñ aware of. >> was a safety issue if itdzñ was, if it, it hasn't been, but is it due to the genetic engineering or is it other factors that you look for when you're inspecting. >> again i'm not aware of any consultation that has resulted in a finding of lack of safety. wäphave the ones we have completed, we obviously have concluded we don't have any questions. there were a handful that did

not go to completion. they were either withdrawn or we were asked to stop the review, and i simply don't know the details orc óvz reason. >> what happens when you're asked to stop the review? >> we stop the review, and the products do not go to market. >> okay. so just by stopping the review they don't go to >> so effectively you're doing what a regulator is supposed to do. was with the it rooted in enactments like the federal fungicide and rodenticide act, and do you think these preempt state requirements? >> it varies enormously across statutes statutes.#rn i can't answer that question. >> and! statutes, including the one from 1906, been instrumental in consumer protection? >> i can speak to the food and

drug act. i think the answer to the question is yes. it dates from '06 was amended in '38, multiple, multiple times since then, i think7-21v to promote and protect the public health. >> do you have any suggestions in how we might look at some of these acts and make your job more effective? you can get back to us if you want, because i foe, because that's our job.> hd is if you don't have the tools -- >> we're certainly happy to provide technical td (jt whenever you ask us to do that. >>v t%4>- you mr. chairman. i'll yield back my time. >> thank you. we'll recognize the gentleman, mr. sarbanes for five minutes for questions. >> thank you. random questions picking up on your allergy discussion. presumably, i mean now you're suggesting that most ingredients to which there's an allergy of

any significance, you require that that be disclosed. >> congress required it in 2004. >> okay. and but fda would determine at some point that if the number of people affected by that dwroents in terms of an allergy reached a certain percentage of the would flip into a banning ofso:3ç the ingredient, like where's that lean? >> no. it's not banning.j it's a disclosure requirement. disclosure in the labeling as the chairman was reminding me earlier, so that if we were to conclude that a food ingredient that is not on the list in the 2004 statute, that met a certain threshold, i can't answer what that threshold is. in terms of percentage of

population, we would require a disclosure of it on the label. >> so you're talking about it meeting a certain threshold in terms of requiring disclosure. i'm asking you whether there's a threshold one might meet that(çq>t z.+$áutttáu hat you would just ban it? i mean, if 95% of the population's allergic to something -- >> of course. the, let me give you an z the oldest adulteration provision in the law says among other things if a food contains a substance that renders the food ordinarily injurious to health the food's adulterated. and if it's adulterated it's prohibited from interstate commerce. of course, if there was an ingredient that caused an illness in 98% of the population

and people ate the food and got the ingredient we would ban the ingredient. i'm sorry. i thought you were trying to get to the disclosure. >> i'm curious about when industry has to go change gh r(t&háhp &hc% labels. in response to, say, somegmhj consultation exercise where everybody realizesxñ that that's the right thing to do or something more prescriptive that you require -- well first of all, is it the case that these labels get created and they're sort of static for extended periods of time? or, in your experience, is labeling constantly being revised and updated, both with respect to content potentially but also in terms of the form of it, the9.$u(v it looks onb< packaging. >> i really don't know.

just not familiar enoughí2xñ with industry practice. >> do you, can dl you, in your 30 years, when was the last time8jd that you can remember that something fda did or some realization that the food ind5ñzm significant, across-the-board change in labeling? >> well, the one that comes immediately to mind is nutrition facts. >>÷(fñ y:u6mm-hm. >> which is now the basic, heart of it is now, i guess, about 20 years old. we required the0á&?í disclosure of trans transfat. >> so that -- >> eight nine, ten years ago, whereas16y i mentioned ea